This disclosure relates to an apparatus and method for medical products labeling. More particularly, this disclosure relates to sterile labeling and packaging of medications, solutions, supplies and other medical material that may be used in a sterile environment, such as an operating room.
While the disclosure is particularly directed towards a peel pack containing one or more sterile labels, which may be applied to medications for use within a sterile field, and thus will be described with specific reference thereto, it will be appreciated that this disclosure may have usefulness in other fields and applications. For example, this disclosure may be used in a variety of settings where sterility is useful and/or mandated.
By way of background, medical errors are responsible for many injuries and deaths in the world. Many of these medical errors are medication errors. Medication errors are preventable episodes that cause or lead to inappropriate medication administration and cause a patient harm while the medication is under the control of the health care professional, patient and/or consumer. Studies show that when medication errors occur in the operating room, they are more likely to cause the patient harm than when they occur in other areas in the hospital and/or in the patient's home. In an operating room environment, many of these medication errors are the result of unlabeled or inadequately labeled medications and solutions used within the sterile field.
Generally, medications, solutions and supplies are delivered to hospitals in containers supplied by the manufacturers. The materials inside of containers destined for the operating room or other sterile procedure areas, are sterile. However, the outside of the containers are not sterile. This is in part because the outside of the containers are handled outside of the sterile field. In the operating room, a circulating nurse may carry the container to the sterile field, open it and dispense the sterile contents into a container within the sterile field without contamination of the sterile field. The circulating nurse often works with a scrub nurse or certified surgical technologist who is dressed in a sterile gown and gloves and maintaining a sterile field. The scrub nurse handles the sterile medication without compromising the sterility. The circulating nurse initiates the process of aseptically dispensing the medication to the sterile field. The circulating nurse/licensed medical professional handles the non-sterile container (the contents of which are sterile) and pours or otherwise dispenses the medication, using aseptic technique, onto the sterile field. The scrub nurse must then label the container and any additional apparatus used to administer the medication from that point. The medications are labeled according to practice standards mandated by various government agencies such as Centers for Medicare and Medicaid Services (CMS); and, other accrediting and standard setting organizations such as the American Nurses Association (ANA), the Association of periOperative Registered Nurses (AORN), The Joint Commission (TJC, formerly the Joint Commission on Accreditation of Health Organizations (JCAHO)), Healthcare Facilities Accreditation Program (HFAP), etc. Current specific requirements include medication/solution name, strength, amount (if not apparent), diluent (if applicable) and expiration date/time.
These standards are in place to help reduce medication errors. Therefore, the scrub nurse must apply a sterile label to the container for these medications, at the time the medications are dispensed to the sterile field. For example, if a medication is dispensed into a cup, basin (or receptacle) and then subsequently drawn into a syringe, the cup or basin and the syringe must both be labeled with the name of the medication and other pertinent information using a sterile label.
This process of writing out all pertinent information on a label can be time consuming and create an unnecessary opportunity for error for a scrub nurse who may have other urgent duties. However, a circulating nurse generally is not able to handle the labeling procedures because the circulating nurse is not within the sterile field and would contaminate the sterile field if he or she labels the medication.
U.S. Pat. No. 7,815,123 to Conner et al. discloses a solution to the need in the industry to provide a system and apparatus which will reduce the opportunity for labeling errors in the operating room. In particular, the '123 patent discloses a method and system for delivering sterile labels to a sterile field by a circulating medical professional. A peel pack containing one or more sterile labels that contain information directly corresponding to a particular medication or solution is removably attached to the container of such medication or solution (e.g., a large bottle, a box, a flat package, etc.). As such, a licensed medical professional can detach the peel pack from the container, open the peel pack, and dispense sterile labels to a scrub nurse in the sterile field without compromising the sterility of the label. The scrub nurse can then immediately and accurately verify the label, label and prepare the medication according to recommended practices. The scrubbed medical professional may also write down the date and time of dispensing or other pertinent information on the labels.
While the system, method and device of the '123 patent has been met with commercial success, there remains room for improvement.